Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03961620 |
| Other study ID # |
2018/630 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 9, 2019 |
| Est. completion date |
February 22, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Corporacion Parc Tauli |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study TAULÍ-PREVINQ-WARM will assess the rate of perioperative hypothermia in patients
submitted to major surgical procedures at the operating room main area (and at the ambulatory
surgery building for ophthalmologic major procedures) of the Parc Taulí, Hospital
Universitari, Sabadell, Barcelona.
Description:
Treatment plan The month before the start of the study, investigators will double check with
the administrative personnel the potential candidates to be included in to the study.
Furthermore, investigators will meet with the responsible of each surgical specialty to
delineate the adequate staff workload and collaborators needs. To assure the best study
performance and to avoid selection patient bias, patients will be consecutively included in
blocs of each designated surgical specialty.
At the patient admission area and surgical preparation, associated investigators will inform
to candidates and relatives about the project giving the informed form to be signed.
Patient inclusion will include a pilot phase (four to five patients) to teach collaborators
regarding the correct placement of cutaneous sensor, data lecture and registration to the
database. Along with the maintenance department of the hospital, we also assess the correct
installation and function of temperature and humidity sensors at the OR (Mini-datalogger
174H, Instrumentos Testo, S.A. Cabrils, Barcelona). OR temperature and the degree of humidity
will be measured at the specific time points stated at the paragraph of the measurements.
Body temperature (BT) measurements will be performed at the UPQ, anesthesia preparation room,
OR and URPA in those specifically stated time points (Annex 2 and Figure 1).
Because the investigators want to perform a pragmatic study, patients will receive
conventional normothermia preventive measures following the approved local guidelines from
the Anesthesiology Department.
Measurement and data entry Body temperature (BT) Patient's BT will be assessed with the
SpotOn system that encompasses the registration unit (3M SpotOn Control Unit), disposable
sensor (3M SpotOn Control Sensor) along with the cords and electric power unit.
Non-invasive digital BT system monitorization SpotOn, includes a sensor that by adhering to
the lateral side of supra-ocular region, allows for continued registration of BT for the
overall surgical process.
Number of times and sites of BT registration Staff devoted to assess BT measurements. Staff
from 3M, will advise nurses, anesthesiologists and investigators regarding SpotOn
specifications and management at the beginning of the study
Because OR temperature and degree of humidity may have some influence on patient's BT and
thermic comfort both patients and OR staff, OR temperature and humidity will be registered at
the beginning and at the end of surgical procedure. Also, the protocol will take in to the
account weather conditions registered at the MeteoCat and will be included at the data base
regularly. Also, staff from Maintenance of Hospital Facilities and Equipment, will set up and
store data from the OR temperature and humidity sensors (Mini-datalogger 174H, Instrumentos
Testo, S.A. Cabrils, Barcelona).
Data about measures addressed to sustain perioperative normothermia will also be recorded
(see Annex 4)
At the end of surgical procedure the investigators will ask patients and OR staff for running
a visual analogic scale punctuation (1 to 10) regarding the perceived thermal comfort (see
Annex 5)
Length of the study and period of patients recruitment. Because the specific nature of this
prospective observational and pragmatic study, the rate of patients recruitment will be
assessed frequently to accommodate both optimal patient accrual and fair and adequate entry
data. The approximate time for total patients inclusion will be of one year.
Sample size The main objective of the study TAULI-PREVINQ-WARM is to assess the rate of
perioperative hypothermia (<36ªC) at some point during the surgical process in patients
operated on for a major surgical procedure at the Parc Tauli, Hospital Universitari,
Sabadell. Then, sample size has been calculated taking in to the account that roughly 50% of
patients will have some kind of hypothermia with 10% of variability of 95% CI. Assuming a10%
of repository additional patients, 110 patients will be included overall.
Assessment of data results and statistical analysis. The TAULI-PREVINQ-WARM is a pragmatic
study that wants to assess body temperature in surgical patients under regular clinical
conditions. We will perform a descriptive analysis of data by depicting mainly frequency
distribution analysis of the qualitative main variable, HypoTer. The proposed sample size
will allow also for assessing the rate HypoTer at each different surgical areas where
patients are admitted. Also, repeated measures will be compared among different surgical
procedures at the OR taking in to consideration the body surface area under regular
preventive normothermia measures, following the general lineal model. Univariate two-sided
analysis will be perform for all comparisons and parametric or non-parametric analysis will
be performed accordingly. Multivariate analysis might eventually be performed depending of
the rate of events.
